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Topic Title

  • Comparative Effectiveness of Anticholinergic Medications in Patients with Chronic Obstructive Pulmonary Disease (COPD)

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Abstract - Final

Comparative Effectiveness of Anticholinergic Medications in Patients with Chronic Obstructive Pulmonary Disease (COPD)

Topic Abstract

Background

COPD is primarily a disease of the elderly that is associated with tremendous economic burden to society as well a leading source of morbidity and mortality. As a chronic disease, patient management focuses on controlling symptoms of COPD using medications. Anticholinergic medications, which include ipratropium and the more recently introduced tiotropium, are mainstays of symptom management strategies in patients with COPD. However, there is limited evidence to support their effectiveness in terms of impact on health outcomes outside the context of clinical trials. The overall goal of this project is to evaluate the effectiveness of anticholinergic medications, including both ipratropium and tiotropium, compared to other COPD medications.

Objectives

The first aim of the study is to evaluate the risk of mortality, COPD exacerbations, and COPD-related hospitalizations in patients treated with tiotropium compared to similar patients who do not receive tiotropium. A second aim is to compare the likelihood of medication regimen change, which may be a proxy for treatment failure or lack of effectiveness, between patients treated with tiotropium and those treated with other COPD regimens. The third aim is to evaluate the comparative effectiveness of ipratropium to other COPD medications in terms of risk of mortality, COPD exacerbations, and COPD-related hospitalizations.

Methods

Different study designs will be used to separately examine the effectiveness of tiotroprium and ipratropium. Two cohorts will be identified using national VA databases of patients, one prior to the introduction of tiotropium, the other after tiotropium became an unrestricted agent in the VA system. Because tiotropium was not available prior to February of 2004, a pre-2004 cohort created for a prior task order will serve as a source of historical controls. Effectiveness of ipratropium will be evaluated using the data prior to the introduction of tiotropium.

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